2018 in review: Governments start taking access seriously

Market access has become a key focus for governments across the globe in 2018 – though as ever a balance between what is good for the industry and what is good for countries and their healthcare systems is hard to strike.

The new deal introduces an annual cap of 2% on the growth of branded medicine sales to the NHS. Any overspend is rebated by pharma companies, based on their net sales. It is estimated that this will save the NHS £930 million next year.

In return, the government has promised the industry “more and faster NICE appraisals for new medicines” – perhaps six months sooner than at present – as well as earlier engagement to ensure clinicians and the NHS infrastructure are ready to use them.

Perhaps as an early gesture of good will, in December NICE announced new standards for digital products like wearables and healthcare apps that should expedite approval and uptake.

Even before those promises, though, the NHS had already received praise from the industry for its fast uptake of new CAR-T therapies – as the health service quickly struck deals for Gilead’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel), the latter of which was hailed as one of the fastest funding approvals in the NHS’ 70-year history.

But one of the more surprising turnarounds for the UK industry this year was the legalisation of medical cannabis, an issue that was thrust into the spotlight after two boys with epilepsy were denied cannabis oil, sparking outrage.

A Home Office review swiftly followed, and in November the government re-classified certain cannabis-based products as ‘schedule two’ – meaning they have a potential medical purpose. Prior to this, all cannabis was classed as schedule one, indicating that it had no therapeutic value.

Nevertheless, use of medicinal cannabis is still restricted – it can only be used by specialist hospital doctors where there is clear, published evidence of the benefits and where other therapies have failed. GPs cannot prescribe the medicines.

Europe looks to coordinate HTA

As the UK continued to fiercely debate its future relationship with the EU, the European Commission set out proposals this year for more HTA collaboration and harmonisation between the Union’s member states.

The proposals suggest a member state coordination group that can facilitate joint clinical assessment and joint scientific consultations and hopefully prevent duplicated work. The EU-level system would assess the benefits of a new drug, while individual member states would use the findings to inform their pricing negotiations with pharma companies.

It would in effect make bodies such as Germany’s Institute for Quality and Efficiency in Healthcare (IQWIG) and the French Economic Committee for Health Products (CEPS) redundant, replacing divergent Health Technology Assessment (HTA) systems across Europe.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said it backed the proposals in principle, whilst warning of the potential risks of a voluntary approach and stressing the importance of individual countries still being able to have the final say on pricing.

“We believe that EU cooperation on joint clinical assessments and joint scientific consultations has the potential to contribute to expediting patients’ access to medicines in Europe,” an EFPIA spokesperson said. “The pharmaceutical industry therefore strongly supports the requirement to apply and not repeat joint clinical assessment reports at the national level.

“Member states should of course continue to be solely responsible for drawing conclusions on the value of the health technologies concerned as part of national appraisal processes and should retain full competence when it comes to national pricing and reimbursement decision-making.”

Trump tackles pricing

Meanwhile, in the US, drug pricing became a key part of the national conversation as president Donald Trump and his Democrat opponents found a rare thing they could agree on. When the Democrats took back control of the House of Representatives in the midterm elections, Democrat Nancy Pelosi, soon-to-be leader of the House, said: “We will take real, very strong legislative action to negotiate down the price control of prescription drugs that is burdening seniors and families across America.”

Drug pricing had already been a been a key focus for the president; in May Trump published a blueprint to lowering drug prices by increasing competition, cutting regulations and changing incentives for those in the pharma industry. He followed this up in October by signing two pieces of legislation including measures requiring pharmacists to tell patients if there is a low-cost alternative to a branded drug.

Moreover, companies like Pfizer and Novartis announced that they would not be raising drug prices this year in response to pressure from the White House.

Nevertheless, the Democrats think more can be done to help patients in America.

“It’s about stopping the GOP and [Republican Senator] Mitch McConnell’s assault on Medicare and Medicaid, the Affordable Care Act and the healthcare of 130 million Americans living with pre–existing medical conditions,” Pelosi added in her statement.